Health

Some medical researchers who evaluate the effect of a treatment on composite outcomes may not be reporting these studies adequately, according to a review of 167 clinical trials covering 300,276 patients. Composite outcome means the researcher studies the effect of the treatment on more than one outcome. Many studies use death as the final outcome, but others also include other non-fatal endpoints.

Some of the problems with conducting and reporting complicated clinical trials are reviewed. Clinical trials have become complicated because they often evaluate more than one treatment. These types of clinical trials are called factorial trials. Other clinical trials evaluate the effect of the treatment on more than one outcome.

Author: Topol, Eric J., Lauer, Michael S.

Publisher:American Medical AssociationPublication Name:JAMA, The Journal of the American Medical AssociationSubject:HealthISSN:0098-7484Year:2003

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Economic return of clinical trials performed under the pediatric exclusivity program

Article Abstract:

A cohort study of pediatric exclusivity programs are used to quantify the economic return to industry for completing pediatric exclusivity trials. The results have shown that the economic return for pediatric exclusivity is variable, as it can generate lucrative returns or produce more modest returns on investment.

Author: Schulman, Kevin A., Mangum, Barry

Publisher:American Medical AssociationPublication Name:JAMA, The Journal of the American Medical AssociationSubject:HealthISSN:0098-7484Year:2007